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AGFA DR Full Leg Full Spine User Manual

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DR Full Leg Full Spine
User Manual
0179E EN 20210708 1527

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Summary of Contents for AGFA DR Full Leg Full Spine

  • Page 1 DR Full Leg Full Spine User Manual 0179E EN 20210708 1527...

  • Page 2: Table Of Contents

    | DR Full Leg Full Spine | Contents Contents Legal Notice ................4 Introduction to this Manual ........... 5 Scope of this Manual ..........6 About the safety notices in this document ....7 Disclaimer ..............8 Introduction to the Full Leg Full Spine application ....
  • Page 3 DR Full Leg Full Spine | Contents | iii Perform a quality control ......52 Finalize the examination ......55 Storing the FLFS Horizontal Overlay .... 56 Advanced Operation ..........57 Manually adjusting a DR Full Leg Full Spine image ................58 Rejecting a DR Full Leg Full Spine image ..62...

  • Page 4: Legal Notice

    Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or its affiliates. DX-D is a trademark of Agfa NV, Belgium or one of its affiliates. All other trademarks are held by their respective owners and are used in an editorial fashion with no intention of infringement.

  • Page 5: Introduction To This Manual

    DR Full Leg Full Spine | Introduction to this Manual | 5 Introduction to this Manual Topics: • Scope of this Manual • About the safety notices in this document • Disclaimer 0179E EN 20210708 1527...

  • Page 6: Scope Of This Manual

    6 | DR Full Leg Full Spine | Introduction to this Manual Scope of this Manual This manual contains information for the safe and effective operation of the DR Full Leg Full Spine application and the following accessories: • DX Full Leg Full Spine Stand •...

  • Page 7: About The Safety Notices In This Document

    DR Full Leg Full Spine | Introduction to this Manual | 7 About the safety notices in this document The following samples show how warnings, cautions, instructions and notes appear in this document. The text explains their intended use. DANGER:...

  • Page 8: Disclaimer

    8 | DR Full Leg Full Spine | Introduction to this Manual Disclaimer Agfa assumes no liability for use of this document if any unauthorized changes to the content or format have been made. Every care has been taken to ensure the accuracy of the information in this document.

  • Page 9: Introduction To The Full Leg Full Spine Application

    DR Full Leg Full Spine | Introduction to the Full Leg Full Spine application | 9 Introduction to the Full Leg Full Spine application Topics: • Intended Use • Intended User • Configuration • Compliance • System Documentation • Accuracy of Measurements •...

  • Page 10: Intended Use

    10 | DR Full Leg Full Spine | Introduction to the Full Leg Full Spine application Intended Use The intended use of the DR Full Leg Full Spine application is to provide a workflow to acquire images for measurements in the orthopedic field (skeleton).

  • Page 11: Intended User

    DR Full Leg Full Spine | Introduction to the Full Leg Full Spine application | 11 Intended User This manual is written for trained users of Agfa products and trained clinical personnel. Users are considered as the persons who actually handle the equipment as well as the persons having authority over the equipment.

  • Page 12: Configuration

    12 | DR Full Leg Full Spine | Introduction to the Full Leg Full Spine application Configuration The DR Full Leg Full Spine application consists of following components: • DR X-Ray system with automatic positioning • NX Workstation • DX Full Leg Full Spine Stand (type 6001/100) •...
  • Page 13 DR Full Leg Full Spine | Introduction to the Full Leg Full Spine application | 13 Figure 2: Protection shield Stitching grid Ruler Figure 3: FLFS Horizontal Overlay 0179E EN 20210708 1527...

  • Page 14: Compliance

    14 | DR Full Leg Full Spine | Introduction to the Full Leg Full Spine application Compliance General • The DX Full Leg Full Spine Stand, DX FLFS Horizontal Overlay and DR 600 FLFS Horizontal Overlay have been designed in accordance with...

  • Page 15: System Documentation

    DR Full Leg Full Spine | Introduction to the Full Leg Full Spine application | 15 System Documentation The documentation shall be kept with the system for easy reference. The most extensive configuration is described within this manual, including the maximum number of options and accessories.

  • Page 16: Accuracy Of Measurements

    16 | DR Full Leg Full Spine | Introduction to the Full Leg Full Spine application Accuracy of Measurements Distance measurements on DR Full Leg Full Spine images in NX are displayed with a resolution of one or more decimal places (such as 0.01 cm). You should be aware that the real measurement accuracy is generally considerably lower for a number of different reasons, many beyond the control of the product.

  • Page 17: Product Complaints

    DR Full Leg Full Spine | Introduction to the Full Leg Full Spine application | 17 Product Complaints Any health care professional (for example a customer or a user) who has any complaints or has experienced any dissatisfaction with the quality, durability, reliability, safety, effectiveness, or performance of this product must notify Agfa.

  • Page 18: Labels

    18 | DR Full Leg Full Spine | Introduction to the Full Leg Full Spine application Labels Date of manufacture Manufacturer Medical device Serial number Production lot number Unique device identifier, in text format and in machine readable format The most recent version of this docu- ment is available on http://www.agfa-...
  • Page 19 DR Full Leg Full Spine | Introduction to the Full Leg Full Spine application | 19 Table 2: DX FLFS Horizontal Overlay (type 6001/200), DR 600 FLFS Horizontal Overlay (type 6001/220) Label Meaning Type label Figure 5: Example of the type label...

  • Page 20: Cleaning And Disinfection

    20 | DR Full Leg Full Spine | Introduction to the Full Leg Full Spine application Cleaning and Disinfection All appropriate policies and procedures should be followed to avoid contamination of the user/staff, patients and other equipment. All existing universal precautions should be extended to avoid coming into contact with patient or close contact with patient or potential contaminations.

  • Page 21: Maintenance

    DR Full Leg Full Spine | Introduction to the Full Leg Full Spine application | 21 Maintenance The DX Full Leg Full Spine Stand and the FLFS Horizontal Overlay do not require maintenance. 0179E EN 20210708 1527...

  • Page 22: Environmental Protection

    22 | DR Full Leg Full Spine | Introduction to the Full Leg Full Spine application Environmental protection The stitching grid contains lead, can be taken out, and disposed separately. For more detailed information about disposal of this product, please contact your local Agfa service organization.

  • Page 23: Safety Directions

    DR Full Leg Full Spine | Introduction to the Full Leg Full Spine application | 23 Safety Directions WARNING: Safety is only guaranteed when an Agfa certified field service engineer has installed the product. WARNING: The following actions may lead to serious risk of injury and...
  • Page 24 24 | DR Full Leg Full Spine | Introduction to the Full Leg Full Spine application CAUTION: Strictly observe all warnings, cautions, notes and safety markings within this document and on the product. 0179E EN 20210708 1527...

  • Page 25: Getting Started

    DR Full Leg Full Spine | Getting started | 25 Getting started Topics: • Basic Features • Basic Workflow using the DX Full Leg Full Spine Stand • Basic Workflow using the FLFS Horizontal Overlay • Advanced Operation 0179E EN 20210708 1527...

  • Page 26: Basic Features

    26 | DR Full Leg Full Spine | Getting started Basic Features • Automatic workflow. To create a DR Full Leg Full Spine image, a set of partial images is acquired in a completely automated workflow, using the automatic positioning of the X-Ray system.

  • Page 27: Basic Workflow Using The Dx Full Leg Full Spine Stand

    DR Full Leg Full Spine | Getting started | 27 Basic Workflow using the DX Full Leg Full Spine Stand Topics: • Retrieve the patient info • Select the exposure • Prepare the Full Leg Full Spine configuration • Prepare the examination •...

  • Page 28: Retrieve The Patient Info

    28 | DR Full Leg Full Spine | Getting started Retrieve the patient info In the operator room at the NX workstation: 1. When a new patient comes in, define the patient info for the exam. 2. Start the exam.

  • Page 29: Prepare The Full Leg Full Spine Configuration

    DR Full Leg Full Spine | Getting started | 29 Prepare the Full Leg Full Spine configuration In the examination room, position the X-Ray system and the DX Full Leg Full Spine Stand: 1. To use a portable DR Detector, insert it in the radiographic wall stand DR bucky.
  • Page 30 30 | DR Full Leg Full Spine | Getting started Figure 6: Fixation locks 1. Locking lever 2. Unlocking lever 4. Position the footsteps as required for the application. The footsteps can be positioned in three configurations: Table 3: Footsteps configurations Minimum height (approx.
  • Page 31 DR Full Leg Full Spine | Getting started | 31 When performing a FLFS examination, the system imposes limits to the bottom and the top of the region of interest, depending on the X-Ray system installation. When performing a Full Leg examination, the footsteps must be positioned to accommodate for the system limitations to the region of interest.

  • Page 32: Prepare The Examination

    32 | DR Full Leg Full Spine | Getting started Prepare the examination In the examination room, position the patient and specify the region of interest for the examination: 1. Position the patient. WARNING: Monitor the patient position (hands, feet, fingers, etc.) with special care to avoid injury to the patient caused by unit movements.
  • Page 33 DR Full Leg Full Spine | Getting started | 33 STITCHING ROI Top ROI Bottom Cancel Positioning Programs Generator Figure 9: Values for region of interest on DX-D 300 • Top: read the top of the region of interest on the vertical ruler of the DX Full Leg Full Spine Stand.

  • Page 34: Prepare The X-Ray System For The Examination

    34 | DR Full Leg Full Spine | Getting started Prepare the X-Ray system for the examination Prepare the X-Ray system for the examination: 1. On the touch screen console, touch the Set button. CAUTION: Before initiating automatic movement, check the position of the floor mount locks of the DX Full Leg Full Spine Stand.

  • Page 35: Check The Exposure Settings

    DR Full Leg Full Spine | Getting started | 35 Check the exposure settings The availability of following controls depends on the configuration. In the operator room at the software console: The NX Image Overview pane displays the empty thumbnails for the exposures that are required for the examination.
  • Page 36 36 | DR Full Leg Full Spine | Getting started Confirmation button Figure 11: Edit exposure settings for partial images 0179E EN 20210708 1527...

  • Page 37: Execute The Exposure

    DR Full Leg Full Spine | Getting started | 37 Execute the exposure In the operator room: Press the exposure button to execute the examination. Hold the exposure button pressed until three beeps are heard from the NX Workstation to indicate that the examination has finished.

  • Page 38: Perform A Quality Control

    38 | DR Full Leg Full Spine | Getting started Perform a quality control In the operator room at the NX workstation, the DR Full Leg Full Spine image is displayed in the Stitching pane. Figure 12: Stitching pane Stitching is applied based on grid markers in the stitching grid and a correction is applied based on the alignment of the anatomical information in the image.
  • Page 39 DR Full Leg Full Spine | Getting started | 39 Button Parameter Indication that patient movement is detected. Indication that automatic stitching has been performed based on the stitching grid. Indication that manual corrections have been applied to the align- ment of the partial images.
  • Page 40 40 | DR Full Leg Full Spine | Getting started M Indication that manual corrections have been applied to the align- ment of the partial images. G Indication that automatic stitching has been performed based on the stitching grid. A Indication that automatic stitching has been performed based on the alignment of the anatomical information in the image.

  • Page 41: Finalize The Examination

    DR Full Leg Full Spine | Getting started | 41 Finalize the examination In the operator room: 1. Let the patient step down from the DX Full Leg Full Spine Stand. If needed, release the patient belt. The patient may need help to step down from the DX Full Leg Full Spine Stand.

  • Page 42: Basic Workflow Using The Flfs Horizontal Overlay

    42 | DR Full Leg Full Spine | Getting started Basic Workflow using the FLFS Horizontal Overlay Topics: • Retrieve the patient info • Select the exposure • Prepare the Full Leg Full Spine configuration • Prepare the examination •...

  • Page 43: Retrieve The Patient Info

    DR Full Leg Full Spine | Getting started | 43 Retrieve the patient info In the operator room at the NX workstation: 1. When a new patient comes in, define the patient info for the exam. 2. Start the exam.

  • Page 44: Prepare The Full Leg Full Spine Configuration

    44 | DR Full Leg Full Spine | Getting started Prepare the Full Leg Full Spine configuration In the examination room, position the X-Ray system and the FLFS Horizontal Overlay: 1. To use a portable DR Detector, insert it in the radiographic table DR bucky.
  • Page 45 DR Full Leg Full Spine | Getting started | 45 FLFS Horizontal Overlay Figure 14: FLFS Horizontal Overlay on radiographic table 0179E EN 20210708 1527...

  • Page 46: Prepare The Examination

    46 | DR Full Leg Full Spine | Getting started Prepare the examination In the examination room, position the patient and specify the region of interest for the examination: 1. Center the tabletop in transversal direction. It is recommended to adjust the height of the radiographic table to its lowest position.
  • Page 47 DR Full Leg Full Spine | Getting started | 47 Figure 16: Values for region of interest on DX-D 600 • Top: read the top of the region of interest on the ruler of the FLFS Horizontal Overlay. This is the start position.

  • Page 48: Prepare The X-Ray System For The Examination

    48 | DR Full Leg Full Spine | Getting started Prepare the X-Ray system for the examination Prepare the X-Ray system for the examination: 1. On the touch screen console, touch the Set button. 2. Press and hold the button that moves the X-ray system to the automatic position.

  • Page 49: Check The Exposure Settings

    DR Full Leg Full Spine | Getting started | 49 Check the exposure settings The availability of following controls depends on the configuration. In the operator room at the software console: The NX Image Overview pane displays the empty thumbnails for the exposures that are required for the examination.
  • Page 50 50 | DR Full Leg Full Spine | Getting started Confirmation button Figure 18: Edit exposure settings for partial images 0179E EN 20210708 1527...

  • Page 51: Execute The Exposure

    DR Full Leg Full Spine | Getting started | 51 Execute the exposure In the operator room: Press the exposure button to execute the examination. Hold the exposure button pressed until three beeps are heard from the NX Workstation to indicate that the examination has finished.

  • Page 52: Perform A Quality Control

    52 | DR Full Leg Full Spine | Getting started Perform a quality control In the operator room at the NX workstation, the DR Full Leg Full Spine image is displayed in the Stitching pane. Figure 19: Stitching pane Stitching is applied based on grid markers in the stitching grid and a correction is applied based on the alignment of the anatomical information in the image.
  • Page 53 DR Full Leg Full Spine | Getting started | 53 Button Parameter Indication that patient movement is detected. Indication that automatic stitching has been performed based on the stitching grid. Indication that manual corrections have been applied to the align- ment of the partial images.
  • Page 54 54 | DR Full Leg Full Spine | Getting started M Indication that manual corrections have been applied to the align- ment of the partial images. G Indication that automatic stitching has been performed based on the stitching grid. A Indication that automatic stitching has been performed based on the alignment of the anatomical information in the image.

  • Page 55: Finalize The Examination

    DR Full Leg Full Spine | Getting started | 55 Finalize the examination In the operator room: 1. Let the patient step down from the radiographic table. The patient may need help to step down from the radiographic table. 2. Remove the FLFS Horizontal Overlay from the radiographic table and store it.

  • Page 56: Storing The Flfs Horizontal Overlay

    56 | DR Full Leg Full Spine | Getting started Storing the FLFS Horizontal Overlay To safely store the FLFS Horizontal Overlay while it is not in use: Hang the FLFS Horizontal Overlay on the hook on the wall or on a flat surface.

  • Page 57: Advanced Operation

    DR Full Leg Full Spine | Getting started | 57 Advanced Operation Topics: • Manually adjusting a DR Full Leg Full Spine image • Rejecting a DR Full Leg Full Spine image • Making measurements 0179E EN 20210708 1527...

  • Page 58: Manually Adjusting A Dr Full Leg Full Spine Image

    58 | DR Full Leg Full Spine | Getting started Manually adjusting a DR Full Leg Full Spine image Topics: • To rotate all partial images • To stitch a set of partial images • To align the partial images based on their projection on the stitching grid •...
  • Page 59 DR Full Leg Full Spine | Getting started | 59 structures in the overlapping area are not aligned, stitching can be adjusted manually. To align the partial images based on their projection on the stitching grid To align the partial images based on their projection on the stitching grid: Click Grid.
  • Page 60 60 | DR Full Leg Full Spine | Getting started The new alignment is applied to each stitching area. Next to the stitching areas this label is displayed, as well as the vertical and horizontal relative position of the partial images.
  • Page 61 DR Full Leg Full Spine | Getting started | 61 Table 8: Manual alignment Adjusting the posi- Right click-hold the image and drag the mouse tion of the lower im- arrow to any direction. Press the SHIFT or CTRL button while dragging the mouse arrow to adjust the vertical or horizon- tal alignment only.

  • Page 62: Rejecting A Dr Full Leg Full Spine Image

    1. Reject each partial image. 2. If the DR Full Leg Full Spine image was created, reject this image also. No images will be sent and a thumbnail for a new DR Full Leg Full Spine examination is created. 0179E EN 20210708 1527...

  • Page 63: Making Measurements

    Projection of the object on the stitching grid. This is the measured distance on the DR Full Leg Full Spine image on NX if no calibration is applied. Projection of the object on the DR Detector. This is the measured distance on a partial image on NX.
  • Page 64 Source image distance (SID). This distance is received together with the X- Ray generator parameters. Figure 32: Making measurements on DR Full Leg Full Spine images The respective distances between the plane in which the measurement is made, the stitching grid, the DR Detector and the X-ray tube are used to calculate the Estimated Radiographic Magnification Factor to calibrate the distance measurement on NX.

  • Page 65: Problem Solving

    DR Full Leg Full Spine | Problem solving | 65 Problem solving Topics: • Anatomical stitching is not optimal • Stitching fails • Full Leg Full Spine examination is interrupted • Part of the image is masked by the black border •...

  • Page 66: Anatomical Stitching Is Not Optimal

    The patient has changed position during the examina- tion. Brief Solution Manually adjust the DR Full Leg Full Spine image. If the partial images cannot be manually adjusted, click Cancel in the Stitching pane. No DR Full Leg Full Spine image is available. 0179E EN 20210708 1527...

  • Page 67: Stitching Fails

    DR Full Leg Full Spine | Problem solving | 67 Stitching fails Table 10: Problem: Stitching fails Details The partial images cannot be stitched because the grid markers in the stitching grid are not visible in the parti- al images.

  • Page 68: Full Leg Full Spine Examination Is Interrupted

    Full Leg Full Spine examination is interrupted Table 11: Problem: Examination is interrupted Details The DR Full Leg Full Spine examination is aborted before it has completely finished. Cause The exposure button is released by the user before the complete examination has finished.

  • Page 69: Part Of The Image Is Masked By The Black Border

    DR Full Leg Full Spine | Problem solving | 69 Part of the image is masked by the black border Details During the automatic collimation process, NX normally applies black borders to the image. These black borders are intended to mask non relevant areas of the images.
  • Page 70 70 | DR Full Leg Full Spine | Problem solving 6. To display the collimation area, select the icon below. To draw a polygonal collimation area: 1. Select an image in the Image Overview pane. 2. In the Editing window, from the first drop-down list in the Image Processing tool section, select the icon below.

  • Page 71: Bright Area Where Partial Images Overlap

    DR Full Leg Full Spine | Problem solving | 71 Bright area where partial images overlap Table 12: Problem: Bright area where partial images overlap The stitched image may show a bright area where the partial images tails overlap. Cause The increased brightness is a result of the image processing that is applied when combining the partial images.

  • Page 72: Technical Data

    72 | DR Full Leg Full Spine | Technical Data Technical Data Topics: • DX Full Leg Full Spine Stand • DX FLFS Horizontal Overlay • DR 600 FLFS Horizontal Overlay 0179E EN 20210708 1527...

  • Page 73: Dx Full Leg Full Spine Stand

    DR Full Leg Full Spine | Technical Data | 73 DX Full Leg Full Spine Stand Table 13: DX Full Leg Full Spine Stand technical data Labeling IEC 60601-1 chapter 9 TÜV SÜD Test program non-electrical medi- cal support system...

  • Page 74: Dx Flfs Horizontal Overlay

    74 | DR Full Leg Full Spine | Technical Data DX FLFS Horizontal Overlay Table 14: DX FLFS Horizontal Overlay technical data Dimensions Width: 615 mm Length: 1300 mm Thickness: < 4 mm Weight approx. < 5 kg Mylar Back X-ray Absorption <...

  • Page 75: Dr 600 Flfs Horizontal Overlay

    DR Full Leg Full Spine | Technical Data | 75 DR 600 FLFS Horizontal Overlay Table 15: DR 600 FLFS Horizontal Overlay technical data Dimensions Width: 632 mm Length: 1300 mm Thickness: < 4.5 mm Weight approx. < 5 kg Mylar Back X-ray Absorption <...

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